Rillieux La Pape, N/A, France
Medicrea International recalls
9 recalls recorded since 2018, most recently on 29 October 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)4
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 October 2025
- Reason
- Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1039-2026, Z-1038-2026
- Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Ongoing Class II Medical devices
- Recall started
- 3 December 2024
- Reason
- Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Argentina Australia Belgium Brazil Bulgaria Chile Czech Republic Denmark Finland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1118-2025
- UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD
Ongoing Class II Medical devices
- Recall started
- 12 July 2023
- Reason
- There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Distribution
- US nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2461-2023, Z-2460-2023, Z-2456-2023, Z-2453-2023, Z-2459-2023, Z-2462-2023, Z-2455-2023, Z-2452-2023, Z-2457-2023, Z-2458-2023, Z-2454-2023
- IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
- IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
- IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253,
- IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
- GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿
- IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral f
- IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fu
- IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 8 October 2020
- Terminated
- 9 May 2024
- Reason
- Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
- Distribution
- CA Foreign:France, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0463-2021
- MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Terminated Class II Medical devices
- Recall started
- 28 January 2020
- Terminated
- 17 March 2023
- Reason
- An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1472-2020, Z-1473-2020
- Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B360065
- Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590
Terminated Class II Medical devices
- Recall started
- 11 November 2019
- Terminated
- 14 October 2020
- Reason
- Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
- Distribution
- CA, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1234-2020
- Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Terminated Class II Medical devices
- Recall started
- 2 October 2019
- Terminated
- 8 February 2021
- Reason
- Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
- Distribution
- OH, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1156-2020
- Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Ongoing Class II Medical devices
- Recall started
- 16 September 2019
- Reason
- Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0827-2020, Z-0828-2020
- Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
- Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Terminated Class II Medical devices
- Recall started
- 27 June 2019
- Terminated
- 19 November 2020
- Reason
- It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.
- Distribution
- US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0753-2020
- Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.